Our November MedTech news roundup covers the recent Swiss-UK MRA, Swiss Parliament’s mandate to the Federal Council to adapt national law regarding medical devices, updates from the MDCG regarding Notified Body requirements and Authorised Representatives, an announcement from MedTech Europe on eIFU regulations, as well as news and guidance from the FDA regarding cybersecurity modernisation, referencing the definition of “device”, and suggested formats for “deficiencies”. Read on for more…
On 17 November, Switzerland and the United Kingdom signed an agreement on the mutual recognition of conformity assessments. This means that in certain sectors, product testing by a UK conformity assessment body is no longer required for exports from Switzerland to the UK. The agreement will be provisionally applied from 1 January 2023 and will enter into force by 28 February 2023. Find out more here.
On 28 November, politicians made the decision in favour of adapting national law to have Switzerland recognise medical devices with FDA approval for the care of its own population. Until now, patients in Switzerland have only been able to receive treatment with medical devices that have an EU certificate. Swiss Medtech has welcomed the decision, and now calls for the order to be implemented quickly and pragmatically. Read more on this here.
MDCG 2019-6 Rev.4 presents questions and answers on requirements relating to notified bodies under MDR and IVDR. The varied issues covered by the document have been identified in the context of joint assessments, and span organisational & general requirements, resources requirements, and process requirements. Read more here.
MedTech Europe has called on the European Commission and the Member States to amend Regulation (EU) 2021/2226 regarding Electronic Instructions for Use, to allow an expanded use of electronic format IFU for all medical devices used by professionals.
The call comes following MedTech Europe’s collection of data from healthcare professionals within which clear messages emerged regarding the healthcare sector’s preference for an electronic format IFU.
MedTech Europe believes that the current regulation “falls short of the needed legislation for a digital era that allows for the use of electronic format Instructions for Use (eIFU) for all professional use medical devices.” Read more on this here.
The EU commission has published the results of a Notified Bodies Survey on certifications and applications regarding MDR & IVDR. The data captured spans MDD / AIMDD valid certificates, MDR and IVDR applications & certificates, as well as MDR & IVDR completeness checks and time to reach certification. Access the full survey results here.
MDCG 2022-16 has been written for authorised representatives, manufacturers, and other economic operators, and aims to provide guidance on relevant requirements under MDR and IVDR. The document covers designation and mandate, registration & verification obligations, minimum tasks & responsibilities of authorised representatives, liability, termination of the mandate, change of authorised representative, PRRC, market surveillance, and transitional provisions. Read the full guidance here.
The UK’s MHRA is introducing a 12-month extension to the implementation of the future Medical Device Regulations, with the aim of bringing the new regulations into force by July 2024.
In June this year, the MHRA published the government response to the public consultation on the future regulation of medical devices in the UK. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the market in Great Britain.
Read more about the updated timelines and standstill period here.
The FDA has released a new action plan for approaching cybersecurity, outlining its mission to upgrade, enhance and modernise its defences for assets and data.
During the pandemic, the FDA experienced a 457% increase in reconnaissance activities, denial of service, attempted exploitation, and other cyber incidents against IT infrastructure, including nearly 9.5 billion firewall and intrusion detection blocks monthly.
To address the ever-evolving threat landscape, the FDA is aiming to enhance their current cybersecurity defences by advancing an agency-wide approach to cybersecurity modernisation.
On 17 November, the FDA introduced their Cybersecurity Modernization Action Plan (CMAP), which is the next phase of their enterprise digital approach. The CMAP marks a continuation of the FDA’s digital transformation journey which began in 2019 with the Technology Modernization Action Plan (TMAP) and continued with the Data Modernization Action Plan (DMAP) in 2021, and Enterprise Modernization Action Plan (EMAP) earlier this year. Read more about the CMAP here.
The FDA has issued guidance to enhance clarity regarding references to the terms “device” and “counterfeit device”. The document follows recent amendments to Section 201(h) of the Federal Food, Drug, and Cosmetic Act as a result of the enactment of the Safeguarding Therapeutics Act. You can access the guidance here.
The final guidance is intended to help FDA staff develop a request for additional information required to decide on a medical device marketing application in accordance with the Least Burdensome Provisions of the FD&C Act. Such an FDA request for additional information is known as a “deficiency.”
The guidance also describes suggested formats for FDA staff to use when communicating deficiencies, and for industry to use when responding to requests. Read the full guidance here.
The FDA will be holding a public workshop on the “Appropriate Use of Consensus Standards” via webcast on 7 December 2022, between 13:00 and 15:00 ET.
The purpose of the workshop is to obtain public input on the appropriate use of voluntary consensus standards in premarket submissions for medical devices, and to discuss potential approaches to help facilitate the use of standards in premarket submissions. For more information on the workshop, see here.
That concludes our November MedTech news – our last MedTech news roundup of 2022! Check back in January for our first roundup of 2023. In the meantime, we wish all our readers a safe, restful, and happy holiday season.
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